Public Submissions Sought on NZ Implementation of TPP Intellectual Property Provisions

Up until the end of 1994 the Patents Act allowed for extension of term. However, they were repealed when NZ moved from a 16-year to a 20-year patent term as part of its TRIPs compliance from the beginning of 1995. The TPPA will reintroduce extension of term provisions, albeit with changes to qualifying criteria. Under the TPPA patent extension of term need to be provided for delays in patent grant and delays due to obtaining regulatory approval for pharmaceuticals. In both cases, for New Zealand, it is expected that few extensions of term will be granted.

For delays in patent grant it is proposed that the extension of term will be calculated as follows and that no third party opposition to the granting of an extension of term would be allowed. The extension would be the smaller of:

• the period by which the interval between the filing date of the complete specification and the grant of the patent exceeds five years (less any periods that were disregarded) and
• the period by which the interval between the filing date of the request for examination and the grant of the patent exceeds three years (less any periods that were disregarded).

For delays due to obtaining regulatory approval for pharmaceuticals there are more issues to consider. The most important issues being:

• how “unreasonable curtailment” should be defined
• how the length of any extensions should be calculated
• what patented subject matter should be eligible for extension – patents for pharmaceutical products or for pharmaceutical substances
• what conditions and limitations should be imposed.

It is proposed that “unreasonable curtailment” would apply where marketing approval was obtained after grant and where the marketing approval took more than a (yet to be) specified time period (less any periods that were disregarded).  The time period for biologics would be longer than for small molecule pharmaceuticals.

It is proposed that the extension of term will be the lesser of:

• the period by which the interval specified in the second bullet point above exceeds the specified number of years for small molecule pharmaceuticals or the specified number of years for biologics
• the period between the date of grant of the patent and the date on which marketing approval was granted
• a period of 2 years.

It is proposed that extensions of term will be limited to pharmaceutical substances so that at most only one patent can be extended for a pharmaceutical substance. Pharmaceutical products containing that pharmaceutical substance would not be eligible.

It is proposed that the extension of term would need to be applied for within a (yet to be) specified time period and that at most only one extension of term could be granted for a patent and that only the specified use of the substance would be protected. Third party opposition would apply, in the first instance before the Commissioner.

Other issues for consideration include:

• Civil and criminal prohibitions against circumvention of technological protection measures.
• Performers’ rights.
• Customs power to detain suspected infringing goods.

Author: Quinn Miller